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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device pediatric autism spectrum disorder diagnosis aid
Definition A pediatric Autism Spectrum Disorder diagnosis aid is a prescription device that is intended for use as an aid in the diagnosis of Autism Spectrum Disorder in pediatric patients.
Product CodeQPF
Regulation Number 882.1491
Device Class 2


Premarket Reviews
ManufacturerDecision
COGNOA, INC.
  GRANTED 1
EARLITEC DIAGNOSTICS, INC
  SUBSTANTIALLY EQUIVALENT 1
EARLITEC DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1

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